Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Home-based testing only; Behavioral: "Smart" home-based test for HIV; Behavioral: Reminder letters for clinic-based testing

• Registration Number: NCT02876926
• Lead Sponsor: Brown University

Brief Summary

This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Primary Completion: 2018-02-15
• Study Completion: 2018-02-15
• Results First Submitted: 2018-02-15
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Results First Posted: 2019-04-19
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 65

Inclusion Criteria

• Sex with a partner met online in the past year
• Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis
• Own a smartphone (iOS or Android) with a service contract and data plan
• Have a stable address where mail can be received
• Speak English fluently

Exclusion Criteria

• Having tested for HIV in the last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based testing alone	Home-based testing only	These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.
"Enhanced" home-based testing	"Smart" home-based test for HIV	These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.
Reminders for clinic-based testing	Reminder letters for clinic-based testing	Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received HIV Testing	Up to 28 weeks	Count of the number of participants who reported receiving HIV testing.
Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis	Up to 28 weeks	Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.
Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis	Up to 28 weeks	Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.

Trial Locations

Locations (1)

Brown University School of Public Health; 🇺🇸 Providence, Rhode Island, United States